Patients in Septic Shock Clinical Trial
Official title:
The Effects of a Polyethyleneimine-coated Membrane (oXiris™) for Hemofiltration Versus Polymyxin B- Immobilized Fibre Column (Toraymyxin™) for Hemoperfusion on Endotoxin Activity and Inflammatory Conditions in Septic Shock- A Randomized Controlled Pilot Study
Septic shock has a high mortality risk despite the availability of various treatments.
Endotoxin, that is present in the cell walls of gram-negative bacteria, is a potent trigger
of innate immunity. Endotoxin leads to an activation of a cascade with an overwhelming
systemic overflow of pro- and anti- inflammatory mediators at the early phase of sepsis with
generalized vascular endothelial damage, tissue injury and multi-organ failure.
Extracorporeal blood purification therapies aim to reduce the circulating level of endotoxin.
Different extracorporeal blood purification systems are available. The oXiris™ device
comprises a surface treated AN69 membrane capable to adsorb a large spectrum of plasma
cytokines, such as IL-6 and HMGB1 protein. The positively charged inner surface of the
membrane allows absorbing negatively charged bacterial products such as endotoxin. From an
historical perspective, filters containing AN69-based membranes have been the most commonly
used products for CRRT in the management of critically ill patients and a substantial volume
of published data exist.
Another extracorporeal endotoxin removal therapy is the hemoperfusion with ToraymyxinTM (PMX)
filter, which is a cartridge selectively removing blood endotoxin. PMX is composed of
polymyxin B covalently bonded to polystyrene-derivative fibres. It is well known that the
polarity of the polymyxin B antibiotic binds endotoxin and has bactericidal activity.
Therefore, the rationale underlying extracorporeal therapy with PMX is to remove circulating
endotoxin by adsorption.
- Trial with medical device
n/a